A trial to investigate whether giving albumin to patients with advanced liver cirrhosis will reverse immune suppression and improve outcome from infection.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

Inclusion Criteria

• All patients admitted to hospital with acute onset or worsening of complications of cirrhosis e.g. alcoholic hepatitis, hepatic encephalopathy, ascites, hepatic hydrothorax, hyperbilirubinaemia, oesophageal variceal bleed, any infection precipitating acute decompensation or any other presentation of acute decompensation / acute onset chronic liver failure
• Over 18 years of age
• Predicted hospital admission > 5 days at trial enrolment, which must be within 72 hours of admission
• Serum albumin <30g/l at screening
• Documented informed consent to participate (or consent given by a legal representative)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 757
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 189

Exclusion Criteria

• Advanced hepatocellular carcinoma with life expectancy of less than 8 weeks
• Patients who will receive palliative treatment only during their hospital admission
• Patients who are pregnant
• Severe cardiac dysfunction
• Any clinical condition which the investigator considers would make the patient unsuitable for the trial
• The patient has been involved in a clinical trial of Investigational Medicinal Products (IMPs) within the previous 30 days (including re-randomisation into the RCT)
• Trial investigators unable to identify the patient (by NHS number)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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Recruitment & Eligibility

Study & Design

Related Trials

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Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.

Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.

Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.

Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.

Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.

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